Know Cancer

or
forgot password

Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

Phase II Multicentric Randomized Trial, Evaluating the Best Protocol of Chemotherapy, Associated With Targeted Therapy According to the Tumor KRAS Status, in Metastatic Colorectal Cancer (CCRM) Patients With Initially Non-resectable Hepatic Metastases


Inclusion Criteria:



- Histologically proven colorectal adenocarcinoma,

- Primary tumor of the colon or rectum, resectable or resected at least 3 weeks before
randomization or 4 weeks before the beginning of the study treatment,

- Metastatic disease with synchronous or metachronous (> 3 months after diagnosis of
the primary tumor) hepatic metastasis,

- Non-resectable (with respect to curative intent) hepatic metastasis at presentation.
This criterion must be validated by both a surgeon and a radiologist during the RCP
(Multidisciplinary cancer case presentation committee) patient's evaluation meeting
(either technically non-resectable metastases (absolute contraindication): i.e.
impossibility to resect all metastases in a single operation while preserving at
least 30% of healthy liver tissues and/or impossibility to preserve the portal vein
and hepatic artery homolateral to the liver or a portal pedicle, or due to
oncological non-resectability (relative contraindication): presence of > 5 nodules
and bilateral invasion),

- Hepatic metastases, without spread to other sites except in case of ≤ 3 resectable
pulmonary metastases of diameter < 2 cm, detected by thoracic scanner,

- K-Ras status determined before randomization,

- Measurable disease according to the RECIST V1.1 criteria,

- No prior treatment of the hepatic metastases,

- Previous 5FU +/- oxaliplatin-based adjuvant chemotherapy administered after
colorectal tumor resection is authorized if complete more than 1 year before,

- Age ≥ 18 & ≤ 75 years

- Performance status : ECOG 0 or 1,

- Life expectancy ≥ 3 months,

- Hemoglobin ≥ 9 g/dl,

- Polynuclear neutrophiles ≥ 1500/mm3,

- Platelets ≥ 100 000 mm3,

- Creatinemia ≤ 135 µmol/l (1,35 mg/dl)

- Total bilirubin ≤ 1.25 times the Upper Limit of Normal (ULN).

- Hepatic enzymes ASAT and ALAT < 5 x ULN,

- Negative pregnancy test for women of child-bearing age,

- Information given to the patient and signed informed consent,

- Public Health insurance coverage.

Exclusion Criteria:

- Non metastatic and/or non measurable disease according to the RECIST v1.1 criteria.

- Non-resectable primary tumor (e.g.: T4 tumors) or incomplete resection R2.

- History of intestinal inflammatory disease.

- Specific contraindication to any of the study treatments.

- Patient who have previously received anti-EGFr (e.g., cetuximab) or anti-VEGF
monoclonal antibody treatment (e.g., bevacizumab) or treatment with irinotecan.

- History of cancer considered as not cured.

- Stroke/CVA or pulmonary embolism within 6 months before inclusion.

- Significant concomitant disease such as: coagulopathy, respiratory or cardiac
congestive insufficiency, non-medically controlled/unstable angina pectoris,
myocardial infarction within 6 months prior to study entry, arterial hypertension and
uncontrolled arrhythmia, severe infections.

- Clinical neuropathy, grade ≥1.

- Patient already included in another therapeutic trial using an experimental molecule.

- Pregnant women or women who might become pregnant during the study or lactating
women.

- Men or women who can procreate and who do not abide with the use of a contraceptive
means.

- Persons kept in detention or incapable of giving consent

- Patient unwilling or unable to comply with the medical follow-up required by the
trial because of geographic social or psychological reasons.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The main objective is to compare resection rates (R0 or R1) for hepatic metastases

Outcome Description:

Number of patients (%) with hepatic metastases R0 or R1 resection.

Outcome Time Frame:

at least 4-6 weeks after the end of chemotherapy

Safety Issue:

Yes

Principal Investigator

Marc YCHOU, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Val d'Aurelle

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PRODIGE 14 / ACCORD 21/0905

NCT ID:

NCT01442935

Start Date:

February 2011

Completion Date:

February 2019

Related Keywords:

  • Colorectal Cancer
  • Adenocarcinoma
  • Non-resectable hepatic metastases
  • First-line treatment
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location